European regulators adopted a new guideline on so-called biosimilar antibody drugs on Friday, paving the way for cheaper copies of multi-billion-dollar medicines used to treat cancer and other serious diseases. The new rules are keenly awaited by drug companies and investors, who want to know what level of clinical testing will be required to win approval in Europe for copies of complex antibody-based drugs.
Demands for extensive clinical studies in each disease area would push up the cost of developing biosimilar products. As expected, the European Medicines Agency (EMA) did not publish details of the planned new rules after they were endorsed at its monthly meeting of experts, but said they would be released on its website "shortly". A spokeswoman told Reuters earlier this week that publication could take a couple of weeks.
In a statement, the EMA merely said: "This guideline lays down the non-clinical and clinical requirements for monoclonal antibody-containing medicines claiming to be similar to another one already marketed."
Many industry experts expect a cautious approach, requiring separate clinical trials for different diseases addressed by the same antibody. That would be good news for original producers of monoclonal antibodies, such as Roche and Amgen. For makers of generic drugs, it would push up costs and might limit the field to a few sophisticated and well-funded companies such as Teva, which is working on biosimilars with Lonza; Novartis unit Sandoz; and Hospira.